Heparinized Islets in Clinical Islet Transplantation
|Type 1 Diabetes Mellitus||Procedure: Transplantation of islets with heparin coating|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open Study to Evaluate Safety and Efficacy of Allogenic Islet Transplantation Using Islets Coated With Immobilised Heparin|
- Safety [ Time Frame: 105 days ]Number of and grade of Serious Adverse events during the first 105 days after transplantation and Adverse events during the first 75 days after transplantation.
|Anticipated Study Start Date:||January 2018|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: Open, single arm
Transplantation of islets with heparin coating.
Procedure: Transplantation of islets with heparin coating
Transplantation of islets with heparin coating
Transplantation of islets of Langerhans isolated from donated organs is a promising therapy for diabetes type 1. The results so far have, however, not met with the expectations due to relatively low efficiency. Even in situations where the patients have become insulin-free, it has been estimated that the transplanted islet mass is less than 25% of the islet mass of a healthy individual, which in many cases has required repeated use of insulin injections. The islets are transferred to the patient by an infusion drop to the liver via the portal vein.
Researches within the Nordic Network for Clinical Islet Transplantation have in a series of publications shown that the islets are subject to a violent immunological reaction that is non-specific with regard to the individual patient (IBMIR) during the initial contact with blood (Moberg et al, Lancet 2002, among several). The IBMIR reaction is in the earliest phase mediated by coagulation and complement reactions.
In this study the islets will be surface modified to carry immobilised heparin (Corline Heparin Conjugate) prior to transplantation. The primary objective is to protect the islets from being attacked by IBMIR so that a larger portion of the islets will survive the initial phase and engraft. In a paper published by the research group (Cabric et. al., Diabetes, May 2007), the beneficial effects of immobilised heparin on the islets to counteract IBMIR were shown by experiments at the lab bench and in experimental animals.
The evaluation of the transplantations in this study will be based on metabolic and blood chemistry parameters, similar to the evaluations of other transplanted patients within the Nordic Network.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678990
|Contact: Tomas Lorant||+46 18 email@example.com|
|Department of Transplantation Surgery, Karolinska University Hospital||Not yet recruiting|
|Stockholm, Sweden, SE-141 86|
|Contact: Torbjörn Lundgren, MD +46 73 6994946 firstname.lastname@example.org|
|Principal Investigator: Torbjörn Lundgren, MD|
|Department of Transplantation and Liver Surgery, Uppsala University Hospital||Not yet recruiting|
|Uppsala, Sweden, SE-751 85|
|Contact: Tomas Lorant, MD +46 18 6110000 email@example.com|
|Principal Investigator: Tomas Lorant, MD|
|Principal Investigator:||Tomas Lorant||Uppsala University Hospital|